Generics deal sounds alarm for foreign API makers

Foreign API makers unaccustomed to hosting FDA visitors may soon have to get their houses in order. A deal through which generics makers would pay $299 million in annual user fees to the FDA could fund the T&E to deliver U.S. regulatory inspectors to plants in India, China and elsewhere that now provide 80% of the active ingredients in U.S. drugs.

The idea may even appeal to a U.S. Congress that has lobbied for more foreign inspections at the same time it has threatened severe FDA budget cuts.

The New York Times says the deal could "potentially transform the enormous global medicine trade" and is "almost certain" to pass Congress. Drug safety and security advocate Guy Villax, CEO at generics-maker Hovione, says the agreement is "epoch-making," the Times reports. "Supply chains for many generic drugs often contain dozens of middlemen and are highly susceptible to being infiltrated by falsified drugs." Said FDA Commissioner Margaret Hamburg: "FDA's entire generic drug program would be placed on a much more stable footing."

The deal could be completed in weeks. The annual fees will fund biennial plant inspections--the same frequency as in the U.S.

News of the pending deal comes just weeks after the FDA announced success in an international regulatory pilot program. Through the program, European and Australian regulators worked with the FDA on joint inspections and the sharing of inspection data in a trial of cross-border cooperation.

Although generics makers have long fought fees, the incentive for them now reflects a change in the pharma industry itself. Generics makers are creeping into the brand-drug development and commercialization business, while some branded drugmakers work their way into generics. The carrot for the generics makers is the speedier approval of new products that's part of the deal.

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